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Regulatory Affairs Specialist

Saviance Technology
Waltham, Massachusetts, United States
February 13, 2018

Job Title: - Regulatory Affairs Specialist II

Job Location: Waltham, MA

Duration – 06+ Months

The PRE Team are the experts on the regulatory requirements (GVP, ICH, CFR etc) and process owners for the authoring Global periodic safety reports (PSRs) coordinated by Global Pharmacovigilance & Epidemiology (GPE).

The PRE Team is the GPE representative in inspections and audits responsible for explaining PSR authoring processes owned by the PRE Team.

The PRE is responsible for providing responses to Health Authority Assessment reports regarding PSR content in collaboration with the Global Safety Officer (GSO), Global Safety Sciences and Qualified Person for Pharmacovigilance (QPPV) when applicable.

Through content authoring and project management activities, the PRE ensures Global continuity of the safety messaging within PSRs across applicable regulatory submission documents (RMP, DSUR, RSI) to support final approval and signature by the GSO/QPPV.

The PRE assures PSR submission compliance to global regulatory authorities by fostering productive and supportive relationships with internal participants (GSO, QPPV, Risk Management Office, Global Safety Sciences, System Support Unit) and PSR contributors external to GPE (Global Business Units, Medical functions, Global Regulatory Affairs, Biostatistics and Programming, Clinical Science Operations).

The PRE drives continuous improvement for periodic reporting processes and quality documents.

The PRE oversees vendors participating in periodic reporting activities, provides clear guidance on process expectations and productive feedback to ensure adherence to quality document requirements.

Skills: Proactive project management experience including multi-tasking of deliverables with competing timelines

Flexibility to adapt to changing priorities and delays

Fluency in ICH and GVP guidelines regarding periodic safety report content

Comfortable leading cross-functional meetings in English

Strong interpersonal skills and the ability to collaborate productively in an international and multi-cultural environment

Proficiency in Microsoft applications (Word, Power Point, Excel)

Education: PharmD with a minimum of 5 years of clinical or industry experience and 3-4 years of Pharmacovigilance experience. Or BA/BS with a minimum of 5 years of industry experience and 2 years minimum of Pharmacovigilance experience.